Risk –Benefit Profile of Direct-Acting Oral Anticoagulants in Established Therapeutic Indications: An Overview of Systematic Reviews and Observational Studies

AbstractSince 2008, the direct-acting oral anticoagulants (DOACs) have expanded the therapeutic options of cardiovascular diseases with recognized clinical and epidemiological impact, such as non-valvular atrial fibrillation (NVAF) and venous thromboembolism (VTE), and also in the preventive setting of orthopedic surgical patients. The large body of evidence, not only from pivotal clinical trials but also from ‘real-world’ postmarketing observational findings (e.g. analytical epidemiological studies and registry data) gathered to date allow for a first attempt at verifying a posteriori whether or not the pharmacological advantages of the DOACs actually translate into therapeutic innovation, with relev ant implications for clinicians, regulators and patients. This review aims to synthesize the risk–benefit profile of DOACs in the aforementioned consolidated indications through an ‘evidence summary’ approach gathering the existent evidence-based data, particularly systematic reviews with meta -analyses of randomized controlled trials, as well as observational studies, comparing DOACs with vitamin K antagonists. Clinical evidence will be discussed and compared with major international guidelines to identify whether an update is needed. Controversial clinically relevant safety issues will be also examined in order to highlight current challenges and unsettled questions (e.g. actual bleeding risk in susceptible populations). It is anticipated that the...
Source: Drug Safety - Category: Drugs & Pharmacology Source Type: research

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This study was undertaken to evaluate patient outcomes after open peripheral bypass based on anticoagulation treatment.
Source: Journal of Vascular Surgery - Category: Surgery Authors: Source Type: research
AbstractAtrial fibrillation is the most common cardiac arrhythmia and is a major cause of embolic stroke. In patients at high bleeding risk such as those with hemophilia, the thromboembolic prevention is challenging. We herein present three patients affected by moderate to severe hemophilia and atrial fibrillation that were treated in our Institution between March 2018 and September 2019, with percutaneous left atrial appendage closure. In patients with relative or absolute contraindications to long-term anticoagulant therapy, the left atrial appendage closure could represent a reasonable strategy.
Source: Journal of Thrombosis and Thrombolysis - Category: Hematology Source Type: research
AbstractAtrial fibrillation (AF) patients with mid-range left ventricular ejection fraction (mrEF) of 40 –49% have neither preserved (pEF >  50%) nor reduced (rEF 
Source: Heart and Vessels - Category: Cardiology Source Type: research
PMID: 32233026 [PubMed - in process]
Source: Thrombosis and Haemostasis - Category: Hematology Authors: Tags: J Thromb Haemost Source Type: research
ConclusionsThese three NOAC strategies may have similar safety and efficacy in terms of thromboembolism and major bleeding complications. The total bleeding risk of completely interrupted oral anticoagulants is higher than that of uninterrupted and minimally interrupted NOACs. For thromboembolism, minimally interrupted NOACs, uninterrupted NOACs and continuous VKAs were better than interrupted warfarin.
Source: Cardiovascular Drugs and Therapy - Category: Cardiology Source Type: research
RARITAN, NJ, March 28, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular (CV) events by 15 percent in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization, with similar rates of TIMI[1] major bleeding. VOYAGER PAD is the only study to show a significant benefit...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
This study included 1962 patients who underwent transesophageal echocardiographic examination (TEE) prior to cardioversion or ablation in the years 2014-2018 in three cardiac centers. RESULTS: More than a quarter of AF patients had decreased eGFR (
Source: Cardiology Journal - Category: Cardiology Authors: Tags: Cardiol J Source Type: research
Int J Angiol DOI: 10.1055/s-0040-1702208In atrial fibrillation (AF), oral anticoagulant (OAC) therapy with either vitamin K antagonist or non–vitamin K antagonist is used to prevent thromboembolic complications. In patients who presented with acute coronary syndrome (ACS) and treated by percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces major adverse cardiac events (MACEs) and stent thrombosis. Consequently, in patients with AF who presented with ACS and treated by PCI, the combination of OAC and DAPT, the so-called triple antithrombotic therapy (TAT)...
Source: International Journal of Angiology - Category: Cardiology Authors: Tags: Review Article Source Type: research
RARITAN, N.J., March 20, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today that it will unveil late-breaking data from its leading cardiovascular and metabolism portfolio during the virtual American College of Cardiology’s 69th Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC) on March 28-30, 2020. Notably, four late-breaking abstracts for XARELTO® (rivaroxaban) will be presented, including data from the Phase 3 VOYAGER PAD study in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization.Click to ...
Source: Johnson and Johnson - Category: Pharmaceuticals Source Type: news
Conclusion: In adults with AF after PCI, dual therapy reduces risk for bleeding compared with triple therapy, whereas its effects on risks for death and ischemic end points are still unclear. Primary Funding Source: None. PMID: 32176890 [PubMed - as supplied by publisher]
Source: Annals of Internal Medicine - Category: Internal Medicine Authors: Tags: Ann Intern Med Source Type: research
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